Feminine care products for the delivery of therapeutic substances

ABSTRACT

An absorbent personal care device, such as an interlabial pad, tampon, sanitary pad or liner, or incontinence product adapted to deliver a therapeutic agent to the vaginal epithelium for systemic and topical treatment, the tampon including absorbent material and a formulation including a therapeutic agent, wherein the therapeutic agent is a botanical. The botanical may be, but is not limited to,  Agnus castus , aloe vera, comfrey, calendula, dong quai, black cohosh, chamomile, evening primrose,  Hypericum perforatum , licorice root, black currant seed oil, St. John&#39;s wort, tea extracts, lemon balm, capsicum, rosemary,  Areca catechu , mung bean, borage seed oil, witch hazel, fenugreek, lavender, soy, heath, cranberries, blueberries, azaleas, red onion skin, short red bell peppers, long red bell peppers, beet root extract, capsanthin, whortleberry, lingenberry, chokeberry, sweet rowan, rowanberry, seabuckhrouberry, crowberry, strawberries, or gooseberries.

BACKGROUND

Many disease states and physiological conditions can occur in a woman,including symptoms associated with premenstrual syndrome, menstruation,and menopause. These symptoms may include dysmenorrhea (menstrualcramping), irritability, water retention, moodiness, depression,anxiety, skin changes, headaches, breast tenderness, tension, weightgain, cravings, fatigue, and hot flashes. Symptoms of conditions caninclude itching and other associated sensory maladies.

Many of these symptoms are due to changes in hormonal levels throughoutthe menstrual cycle. Menstrual cramping is associated with increasedlevels of prostaglandin F2α, prostaglandin E2, and in some casesleukotrienes in the endometrium and menstrual fluid. These eicosinoidslead to restricted blood flow to the uterus and increased uterinecontractions, causing pain.

One example is dysmenorrhea, which is the occurrence of painful uterinecramps during menstruation that affects a large number of post-pubescentwomen. The pain of dysmenorrhea originates in the uterus. Variousanalgesics can be effective in limiting the pain from dysmenorrhea; somehave used orally-delivered analgesics, while others have searched foralternative analgesic delivery methods. Attempts have been made todeliver analgesics in the vicinity of the cervix and the vaginal mucosausing various vaginally-inserted devices and methods. A similarsituation exists with many other disease states and physiologicalconditions.

Disposable absorbent devices for the absorption of human exudates arewidely used. These disposable absorbent devices typically have a mass ofabsorbent formed into a desired shape, which is typically dictated bythe intended consumer use. In the area of a catamenial tampon, thedisposable absorbent article is intended to be inserted in a body cavityfor absorption of the body fluids generally discharged during a woman'smenstrual period. One convenient way to position such absorbent tamponsinto a body cavity is through the use of an applicator.

Because many of these symptoms typically occur in conjunction withmenstruation, some have tried to combine an analgesic with a tampon.

SUMMARY OF THE INVENTION

One difficulty in using orally-delivered analgesics is that oral dosesof analgesics large enough to be efficacious can lead to adverse sideeffects, thus limiting the actual dose of the analgesics. Limiting dosesin an attempt to limit those side effects results in an insufficientamount of analgesic delivered to the uterus. In addition, the use ofanalgesics delivered by alternative means, including through the use oftampons, can still cause side effects because of the inherent nature ofthe analgesics.

This invention describes the use of alternative beneficial agents toeliminate the side effects inherent in traditional therapeutic agents.More specifically, this invention describes the delivery of suchalternative beneficial agents from absorbent or non-absorbent femininecare products (such as sanitary napkins, tampons, and interlabialdevices) to promote relief. Through the use of these feminine careproducts, these agents may be used topically or systemically to providerelief.

These beneficial agents promote epithelial health in the vaginal regionby delivering botanical ingredients with a feminine care device. Theidea is to modulate the vaginal environment to enhance the wellness ofthis anatomical region. These benefits can be rather simple, for exampleincreasing comfort by providing moisturization and/or lubricity. Thesebenefits can also be more complex, for example modulating epithelialcell function to address vaginal atrophy. The beneficial agents mayreduce negative sensations such as stinging, burning, itching, etc, orintroduce positive sensations to improve comfort.

This invention describes a therapeutic agent delivery system incooperation with a feminine care product by providing a therapeuticagent delivery system that is integral with or associated with thefeminine care product. The therapeutic agent delivery system includingthe therapeutic agent and carrier components can be any therapeuticagent that will be absorbed into the body through the vaginalepithelium, or deposited topically on the vaginal epithelium, for thepurposes of treating a physiological disease, state, or condition. Oneembodiment is for the therapeutic agent and its delivery system to beapplied to the outer surface of the feminine care product andpredominantly to the surfaces that are in contact with the vaginalepithelium. Other embodiments would provide a reservoir of a therapeuticagent incorporated into the feminine care product to provide for varyingdoses, or a means to provide release of the therapeutic agent over theduration of contact with the vaginal epithelium.

Other objects and advantages of the present invention will become moreapparent to those skilled in the art in view of the followingdescription and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a two piece tampon applicator.

FIG. 2 is a cross-sectional view of the tampon applicator shown in FIG.1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention as described herein will be described for exemplarypurposes using a tampon as an example of a feminine care product. Theinvention, however, applies equally to other forms of products andshould not be limited to the example described herein. In addition,although the example described includes a tampon with absorbentmaterial, a product without absorbent material is also contemplatedwithin the invention. Also contemplated is the use of the inventiondescribed herein in conjunction with non-catamenial feminine productssuch as incontinence products, including female incontinence inserts.

As used herein the term “nonwoven fabric or web” means a web having astructure of individual fibers or threads that are interlaid, but not ina regular or identifiable manner as in a knitted fabric. The term alsoincludes individual filaments and strands, yarns or tows as well asfoams and films that have been fibrillated, apertured, or otherwisetreated to impart fabric-like properties. Nonwoven fabrics or webs havebeen formed from many processes such as for example, meltblowingprocesses, spunbonding processes, and bonded carded web processes. Thebasis weight of nonwoven fabrics is usually expressed in ounces ofmaterial per square yard (“osy”) or grams per square meter (“gsm”) andthe fiber diameters useful are usually expressed in microns. Basisweights can be converted from osy to gsm simply by multiplying the valuein osy by 33.91.

As used herein the term “microfibers” means small diameter fibers havingan average diameter not greater than about 75 microns, for example,having an average diameter of from about 0.5 microns to about 50microns, or more particularly, microfibers may have an average diameterof from about 2 microns to about 40 microns. Another frequently usedexpression of fiber diameter is denier, which is defined as grams per9000 meters of a fiber and may be calculated as fiber diameter inmicrons squared, multiplied by the density in grams/cc, multiplied by0.00707. A lower denier indicates a finer fiber and a higher denierindicates a thicker or heavier fiber. For example, the diameter of apolypropylene fiber given as 15 microns may be converted to denier bysquaring, multiplying the result by 0.89 g/cc and multiplying by0.00707. Thus, a 15 micron polypropylene fiber has a denier of about1.42 (15²×0.89×0.00707=1.415). Outside the United States the unit ofmeasurement is more commonly the “tex”, which is defined as the gramsper kilometer of fiber. Tex may be calculated as denier/9.

As used herein the term “spunbonded fibers” refers to small diameterfibers which are formed by extruding molten thermoplastic material asfilaments from a plurality of fine, usually circular capillaries of aspinneret with the diameter of the extruded filaments then being rapidlyreduced as, for example, described in U.S. Pat. Nos. 4,340,563;3,692,618; 3,802,817; 3,338,992; 3,341,394; 3,502,763; 3,502,538; and3,542,615. Spunbond fibers are quenched and generally not tacky whendeposited onto a collecting surface. Spunbond fibers are generallycontinuous and have average diameters frequently larger than 7 microns,typically between about 10 and 20 microns.

As used herein the term “meltblown fibers” means fibers formed byextruding a molten thermoplastic material through a plurality of fine,usually circular, die capillaries as molten threads or filaments intoconverging high velocity, usually heated, gas (e.g. air) streams whichattenuate the filaments of molten thermoplastic material to reduce theirdiameter, which may be to microfiber diameter. Thereafter, the meltblownfibers are carried by the high velocity gas stream and are deposited ona collecting surface often while still tacky to form a web of randomlydisbursed meltblown fibers. Such a process is disclosed, for example, inU.S. Pat. No. 3,849,241. Meltblown fibers are microfibers that may becontinuous or discontinuous and are generally smaller than 10 microns inaverage diameter.

As used herein “bonded carded webs” or “BCW” refers to nonwoven websformed by carding processes as are known to those skilled in the art andfurther described, for example, in U.S. Pat. No. 4,488,928 which isincorporated herein by reference. Briefly, carding processes involvestarting with a blend of, for example, staple fibers with bonding fibersor other bonding components in a bulky ball that is combed or otherwisetreated to provide a generally uniform basis weight. This web is heatedor otherwise treated to activate the adhesive component resulting in anintegrated, usually lofty nonwoven material.

As used herein the term “polymer” generally includes but is not limitedto, homopolymers, copolymers, such as for example, block, graft, randomand alternating copolymers, terpolymers, etc. and blends andmodifications thereof. Furthermore, unless otherwise specificallylimited, the term “polymer shall include all possible geometricalconfigurations of the material. These configurations include, but arenot limited to isotactic, syndiotactic, and random symmetries.

As used herein, the term “hydrophilic” means that the polymeric materialhas a surface free energy such that the polymeric material is wettableby an aqueous medium, i.e. a liquid medium of which water is a majorcomponent. The term “hydrophobic” includes those materials that are nothydrophilic as defined. The phrase “naturally hydrophobic” refers tothose materials that are hydrophobic in their chemical composition statewithout additives or treatments affecting the hydrophobicity. It will berecognized that hydrophobic materials may be treated internally orexternally with treatments such as surfactants and the like to renderthem hydrophilic.

The term “surface” and its plural generally refer herein to the outer orthe topmost boundary of an object.

As used herein, the phrase “absorbent article” refers to devices whichabsorb and contain body fluids, and more specifically, refers to deviceswhich are placed against or near the skin, or against or near thevaginal vault epithelium, to absorb and contain the various fluidsdischarged from the body.

The term “disposable” is used herein to describe absorbent articles thatare not intended to be laundered or otherwise restored or reused as anabsorbent article after a single use.

FIGS. 1-2 illustrate a tampon applicator 10, including a first member 14and a second member 18, which is designed to house a catamenial tampon22 and provide a comfortable means of inserting the tampon 22 into awoman's vagina.

The tampon applicator 10 includes a first member 14 and a second member18. The first member 14 can be in the form of a spirally wound,convolutely wound or longitudinally seamed hollow tube which is formedfrom paper, paperboard, cardboard, plastic, other suitable material, ora combination thereof. Any plastic in the first member 14 is preferablypolyethylene, but may be polypropylene or other suitable plastic. Thefirst member 14, also commonly referred to as an outer tube, can be ofany suitable dimensional arrangement. For example, the first member 14may be fairly rigid and have a relatively small diameter of about 10 mmto about 20 mm. The first member 14 has a wall 24 that may have apredetermined thickness of about 0.2 mm to about 0.6 mm. The wall 24 canbe constructed from a single ply of material or be formed from two ormore plies which are bonded together to form a laminate. The use of twoor more plies or layers enables the manufacture to use certain materialin the various layers that can enhance the performance of the tamponapplicator 10. When two or more plies are utilized, all the plies can bespirally wound, convolutely wound or longitudinally seamed to form anelongated cylinder. The wall 24 can be constructed using a smooth thinply of material on the outside or exterior surface 26 which surrounds acoarser and possibly thicker ply. When the wall 24 contains at leastthree plies, the middle ply can be the thicker ply and the interior andexterior plies can be smooth and/or slippery to facilitate expulsion ofthe tampon 22 and to facilitate insertion of the first member 14 into awoman's vagina, respectively. By sandwiching a thick, coarser ply ofmaterial between two thin, smooth plies, an inexpensive first member 14can be provided that is very functional. The wall 24 should contain oneto four plies, although more plies can be utilized if desired.

The plies forming the wall 24 can be held together by an adhesive, suchas glue, or by heat, pressure, ultrasonics, etc. The adhesive can beeither water-soluble or water-insoluble. A water-soluble adhesive ispreferred for environmental reasons in that the wall 24 will quicklybreak apart when it is immersed in water. Such immersion will occurshould the first member 14 be disposed of by flushing it down a toilet.Exposure of the first member 14 to a municipal's waste treatment plantwherein soaking in water, interaction with chemicals and agitation alloccur, will cause the wall 24 to break apart and even dissolve in arelatively short period of time.

The inside diameter of the first member 14 is usually less than about0.75 inches (about 19 mm) and preferably less than about 0.625 inches(about 16 mm). Although the exterior diameter of tampons do vary, mosttampons utilized by women have an external diameter of less than about0.75 inches (about 19 mm).

The first member 14 is sized and configured to house the absorbenttampon 22. As stated above, the first member 14 should have asubstantially smooth exterior surface 26 which will facilitate insertionof the first member 14 into a woman's vagina. When the exterior surface26 is smooth and/or slippery, the first member 14 will easily slide intoa woman's vagina without subjecting the internal tissues of the vaginato abrasion. The first member 14 can be coated to give it a high slipcharacteristic. Wax, polyethylene, a combination of wax andpolyethylene, cellophane and clay are representative coatings that canbe applied to the first member 14 to facilitate comfortable insertion.

The first member 14 can be a straight, elongated cylindrical tube formedon a central longitudinal axis X—X (see FIG. 2). It is also possible toform the first member 14 into an arcuate shape. The arcuate or curvedshape can assist in providing comfort when inserting the first member 14into a woman's vagina. With a curved tampon applicator, it is possibleto employ a curved tampon which again may be more comfortable for somewomen to use since the shape of the tampon may better fit the curvatureof a woman's vagina.

Referring to FIG. 1, an insertion tip 32 is shown having a plurality ofpleats or petals 36 that can radially open such that the insertion tip32 has a diameter approximately equal to or greater than the diameter ofthe first member 14. The pleats 36 can be either even or odd in numberand can be equally spaced apart or non-uniformly arranged.

Referring again to FIGS. 1 and 2, the first member 14 can have afingergrip ring 40 located approximate the second end 30. The fingergripring 40 can be integrally formed from the material from which the firstmember 14 is constructed or it can be a separate member that is securedin place by an adhesive or some other type of attachment mechanism. Thefingergrip ring 40 functions to provide a means for the user to grip thefirst member 14 and hold it between her thumb and middle finger. Theuser can then position her forefinger on the free end of the secondmember 18 and orient the first member 14 relative to her vagina whileshe pushes the second member 18 into the first member 14.

As stated above, the tampon applicator 10 includes a second member 18,also commonly referred to as an inner tube. The second member 18, likethe first member 14, can be a spirally wound, a convolutely wound or alongitudinally seamed hollow tube constructed from paper, paperboard,cardboard, plastic, other suitable material, or a combination thereof.Any plastic in the second member 18 is preferably polyethylene, but maybe polypropylene or other suitable plastic. The second member 18 can beconstructed of the same material as the first member 14 or it can bemade out of a different material. The second member 18 may also be asolid stick or use some other unique shape. It is also possible to forma fingergrip ring or flange 44 on the outer end of the second member 18to provide an enlarged surface onto which the user's forefinger canrest. The fingergrip ring 44 thereby functions as a seat for theforefinger and facilitates movement of the second member 18 into thefirst member 14.

In an alternate embodiment (not shown), the first member 14 and secondmember 18 of the tampon applicator 10 may be replaced by a stickapplicator. The stick applicator is used to insert the tampon 22, afterwhich the stick applicator is withdrawn.

A tampon 22 is an absorbent member primarily designed to be worn by awoman during her menstrual period to absorb menses, blood and other bodyfluid. The tampon 22 includes a tampon body 50 and a withdrawal string54. The tampon body 50 is normally compressed into the form of acylinder and can have a blunt, rounded or shaped forward end. The tamponbody 50 has a forward or distal end 58 that is closer to the cervix whenthe tampon 22 is in use. The tampon body 50 also has a proximal end 62that is closer to the vaginal opening when the tampon 22 is in use.

The tampon 22 commonly has a withdrawal string 54 fastened to theproximal end 62 that serves as a means for withdrawing the tampon fromthe woman's vagina. The withdrawal string 54 can be looped through anaperture 74 formed transversely through the tampon body 50. In addition,the withdrawal string 54 can have a knot 78 formed at the free end ofthe string to assure that the string 54 will not separate from thetampon body 50.

Catamenial tampons suitable for use in the present invention include anabsorbent. The absorbent can be formed from fibers that are assembledinto an absorbent sheet or ribbon. Alternatively, the absorbent can beformed from absorbent fibers that are assembled and compressed into agenerally elongated and/or cylindrical configuration. The absorbent isdesirably formed from cellulosic fibers, such as cotton and rayon. Forexample, the absorbent can be 100% cotton, 100% rayon, a blend of cottonand rayon fibers, or other materials known to be suitable for tampons,including artificial fibers such as polyester, polypropylene, nylon orblends thereof. The absorbent may also include degradable fibers. Othertypes of materials or structures may also be used, such as cellulosesponge or a sponge formed from elastomeric materials. When formed, theabsorbent typically includes interstitial space or voids between thefibers or other materials.

Tampons suitable for use in this invention are usually made of absorbentfibers, including one or both of natural and synthetic fibers,compressed into a unitary body of a size that may easily be insertedinto the vaginal cavity. Fiber orientation is typically in a linearly-or radially-wound structure. Tampons are normally made in an elongatedcylindrical form in order that they may have a sufficiently large bodyof material to provide the required absorbing capacity, but may be madein a variety of shapes. The tampon 22 is typically compressed.Compression may be achieved by predominantly axially- orradially-applied pressure. The tampon 22 may be made of various fiberblends including both absorbent and nonabsorbent fibers, which may ormay not have a suitable cover or wrapper. The cover or wrapper forabsorbent products, such as tampons and sanitary napkins, is often madefrom a sheet of spunbonded fibers, e.g., a spunbond polypropylene sheet.The tampon may also include one or more of various treatments to improvethe performance of the tampon, including reduced friction and increasedabsorption, delivery of the therapeutic agent, or both.

The fibers from which the present absorbent products are made may beproduced, for example, by the meltblowing or spunbonding processes,including those producing bicomponent, biconstituent, or polymer blendfibers that are well known in the art. These processes generally use anextruder to supply melted thermoplastic polymer to a spinneret where thepolymer is fiberized to yield fibers which may be staple length orlonger. The fibers are then drawn, usually pneumatically, and depositedon a moving foraminous mat or belt to form the nonwoven fabric. Thefibers produced in the spunbond and meltblown processes are microfibersas defined above. The manufacture of spunbond and meltblown webs isdiscussed generally above.

As mentioned, the nonwoven also may be a bonded carded web. Bondedcarded webs are made from staple fibers, which are usually purchased inbales. The bales are placed in a picker, which separates the fibers. Thefibers are sent through a combing or carding unit, which further breaksapart and aligns the staple fibers in the machine direction to form agenerally machine direction-oriented fibrous nonwoven web. Once the webis formed, it then is bonded by one or more of several known bondingmethods. One such bonding method is powder bonding, wherein a powderedadhesive is distributed through the web and then activated, usually byheating the web and adhesive with hot air. Another suitable bondingmethod is pattern bonding, wherein heated calender rolls or ultrasonicbonding equipment are used to bond the fibers together, usually in alocalized bond pattern, though the web can be bonded across its entiresurface if so desired. Another suitable bonding method, particularlywhen using bicomponent staple fibers, is through-air bonding.

An exemplary absorbent material is a nonwoven web composed of 3.0 denierpolyethylene sheath/polypropylene core bicomponent staple fibers havinga length of 38 millimeters. Such bicomponent fibers can be obtained fromChisso Corporation and are typically supplied with a vendor fiber finishor other treatments. The staple fibers can be sent through an opener anduniformly mixed together before being carded into a web at a line speedof 15.24 meters per minute (50 feet per minute). Once the web is formed,it can be sent through a through-air bonder (drum type) with an airtemperature of 131° C. Typical dwell times within the bonder are between3 and 4.5 seconds. The resultant web, which has a basis weight of 100gsm and a density of 0.06 gm/cm³, can then be wound up on a roll.

A therapeutic agent delivery system including a therapeutic agent can beproduced integrally with the tampon 22. For the purposes of thisinvention, any therapeutic agent that will be absorbed into a user'sbody through the vaginal epithelium for the purposes of treatingdiseases or conditions such as, for example, dysmenorrhea, can be used.Alternatively, or in addition, therapeutic and other beneficial agentssuch as vitamins, hormones, moisturizers, antifungal agents,antibacterial agents, pro-biotic agents that promote the growth ofnormal vaginal bacterial flora, and the like may be similarly delivered.

Therapeutic agents for use in the invention are absorbable through thevaginal epithelium and travel to the uterus by a unique portal of veinsand arteries which are known to exist between the vagina, the cervix andthe uterus. This anastomosis eliminates so called first pass metabolismby the liver, effectively delivering higher concentrations oftherapeutic agent to the uterus than would otherwise be available viaoral dosing. One skilled in the art knows the efficacy of therapeuticagents in such an application when introduced at a particular anatomicallocation.

These beneficial therapeutic agents promote epithelial health in thevaginal region by delivering botanical ingredients with a feminine caredevice. The idea is to modulate the vaginal environment to enhance thewellness of this anatomical region. These benefits can be rather simple,for example increasing comfort by providing moisturization and/orlubricity. These benefits can also be more complex, for examplemodulating epithelial cell function to address vaginal atrophy. Thebeneficial therapeutic agents may reduce negative sensations such asstinging, burning, itching, etc, or introduce positive sensations toimprove comfort.

For example, many therapeutic benefits have been ascribed to a largenumber of different botanical preparations. Preparations may includewater-in-oil emulsions, oil-in-water emulsions, gel, liquid, dispersion,powder, and anhydrous systems, ointment, or salve, such as a botanicaloil in an anhydrous base (e.g., petrolatum), or polyethylene glycolbased systems. Also, botanicals are often prepared or extracted underconditions to generate water-soluble or oil-soluble extracts. Theseextracts are usually compositionally different and may have differentskin and vaginal health benefits. Processing conditions will have aneffect on the type of formulation that can be used and this willrestrict the type of botanical (water or oil type) selected. Therefore,wide ranges of botanicals have utility in this invention. Botanicals canpossess a variety of actives and activities that can include, but arenot necessarily limited to, analgesics, antimicrobials, pro-bioticagents, anti-inflammatory compounds, anti-virals, enzymes, enzymeinhibitors, enzyme substrates, enzyme cofactors, ions, ion chelators,lipids, lipid analogs, lipid precursors, hormones, inflammatorymediators, inflammatory agonists, oxidants, antioxidants, humectants,growth factors, sugars, oligosaccarides, polysaccarides, vasodilators,and potential combinations thereof. It is understood that, for thepurposes of this invention, the botanicals can be combined with anynumber of non-botanical active ingredients as well.

Examples of beneficial botanicals may include, but are not limited to,Agnus castus, aloe vera, comfrey, calendula, dong quai, black cohosh,chamomile, evening primrose, Hypericum perforatum, licorice root, blackcurrant seed oil, St. John's wort, tea extracts, lemon balm, capsicum,rosemary, Areca catechu, mung bean, borage seed oil, witch hazel,fenugreek, lavender, and soy. Vaccinium extracts commonly derived frommany members of the heath family, cranberries such as blueberries, andazaleas (Rhododendron spp.) as well as from red onion skin and short andlong red bell peppers, Beta vulgaris (beet) root extract, and capsanthinmay also be used. Other berries that have applicability arewhortleberry, lingenberry, chokeberry, sweet rowan, rowanberry,seabuckhrouberry, crowberry, strawberries, and gooseberries.

These botanicals can be combined with other beneficial agents including,but not limited to, vitamins, calcium, magnesium, hormones, analgesics,prostaglandin inhibitors, prostaglandin synthetase inhibitors,leukotriene receptor antagonists, essential fatty acids, sterols,anti-inflammatory agents, vasodilators, chemotherapeutic agents, andagents to treat infertility.

The therapeutic agent delivery system may also include carriercomponents to promote the functionality of the therapeutic agent. Forexample, the carrier components may assist the therapeutic agent inabsorbing into, or adhering onto, the tampon body 50. The carriercomponents may assist the release of the therapeutic agent from thetampon body 50, or assist in the absorbency of the therapeutic agentinto the vaginal epithelium. The use of excipients to facilitate theformulation, delivery, stability, and aesthetic properties of a drugdelivery system is well known to those familiar with the art.

In one embodiment, the therapeutic agent and the therapeutic agentdelivery system are applied to the outer surface 82 of the tampon body50, substantially within the application zone 66 and predominantly tothe surfaces that will be in contact with the vaginal epithelium. In analternate embodiment, the formulation including a therapeutic agent maybe applied to a pledget, or to a combination of outer surface andpledget. In another alternate embodiment, the formulation including atherapeutic agent may be applied to degradable fibers in or on thetampon body 50. In still another embodiment, the formulation including atherapeutic agent may be interspersed through the interstitial space inthe absorbent.

As an example, the catamenial tampon 22 includes a permeable cover sheetthat contains a therapeutic agent. In this example, such a tampon 22would have a cover sheet formed from spunbond fibers of a hydrophobicpolymeric material, e.g., a spunbond polypropylene cover layer, with atherapeutic agent coated on the outside of the fibers.

It may not be necessary to impregnate the entire absorbent body of anabsorbent product, such as a tampon 22, with the therapeutic agent.Optimum results both economically and functionally, can often beobtained by concentrating the material on or near an outer surface whereit will be most effective during use.

The formulation including a therapeutic agent may be applied to theabsorbent article using conventional methods for applying a therapeuticagent to the desired absorbent article. For example, unitary tampons maybe dipped directly into a bath having the agent and then can be dried. Aformulation including a therapeutic agent may be applied after thetampon is compressed. The formulation including a therapeutic agent,when incorporated on and/or into the tampon materials, may be fugitive,loosely adhered, bound, or any combination thereof. As used herein theterm “fugitive” means that the formulation including a therapeutic agentis capable of migrating through the tampon materials. For example, atherapeutic agent may be blended together with a polymeric material thatis to be processed into a component of an absorbent or non-absorbentproduct.

Alternatively, a formulation including a therapeutic agent may beapplied directly onto an individual layer of material before it isincorporated into an article to be manufactured, such as an absorbentproduct. For example, an aqueous solution containing a therapeutic agentcan be applied by any method known in the art onto the surface of aporous cover sheet or absorbent layer designed to be incorporated intoan absorbent product. This can be done either during the production ofthe individual layer or during a fabrication process that incorporatesthe layer into the article being manufactured.

Nonwoven webs coated with a formulation including a therapeutic agentcan be prepared by conventional processes. For example, a formulationincluding a therapeutic agent can be applied to one or both sides of atraveling web. Those skilled in the art will appreciate that theapplication can be carried out as an inline treatment or as a separate,offline treatment step. A web, such as a spunbond or meltblown nonwoven,can be directed over support rolls to a treating station includingrotary spray heads for application to one side of web. An optionaltreating station may include rotary spray heads to apply a formulationincluding a therapeutic agent to the opposite side of the web. Eachtreatment station generally receives a supply of treating liquid from areservoir. The treated web may then be dried if needed by passing overdryer cans or other drying means and then wound as a roll or convertedto the use for which it is intended. Alternative drying apparatus suchas ovens, through air dryers, infra red dryers, air blowers, and thelike may also be utilized.

Active ingredients, such as pharmaceutical compounds (e.g., histidines,anti-inflammatory drugs, calcium or potassium channel blockers),antimicrobials, anesthetics, hormones or hormone inhibitors, pH controlagents, and the like, can be provided in any known drug delivery mediumthat is placed within the tampon. An example is microencapsulation ofthe active ingredient in starch, dextran, or other degradable or solublematerials, such that microcapsules placed in the absorbent material ofthe tampon can permit gradual release of the active ingredient uponwetting, an increase in temperature, or physical contact. Another typeof delivery system is the use of polymeric transport systems, which arematerials that absorb materials and will release these materials whenapplied to a substrate.

Combining the active ingredient with a hydrophobic material such as asolidifying agent; wax, solid ester, solid fatty alcohol or acid,hydrogenated vegetable oil, solid triglycerides, natural soft solidmaterials (i.e., cocoa butter), solid alkyl silicones, and the like,allows gradual diffusion of the active ingredient from the hydrophobicmaterial to the body of the wearer, while preventing loss of the activeingredient during gushing of body fluids. In one embodiment, thesolidifying agent can be solid at room temperature but can soften atbody temperature to increase the release rate of the active ingredientonce the product has been in contact with the body for a period of time.

The active ingredient may be combined with a hydrogel material. Uponwetting, the hydrogel material swells, resulting in increased deliveryof the active ingredient from the swollen material.

The active ingredient may also be combined with a substantiallyhydrophobic emollient or lotion that can resist being washed away byaqueous body fluids but which can nevertheless transfer to body surfacesduring use to enhance drug delivery.

Another example is the use of polyethylene glycols with molecularweights greater than 720 as solidifying agents. The active ingredientcan be solubilized or dispersed in polyethylene glycols, which are waterdispersible materials. Contact with water containing body fluids willslowly dissolve the polyethylene glycol and release the activeingredient to the body surface.

Finally, the active ingredient may be placed within a pouch in thetampon, which can release active ingredients by diffusion through apermeable membrane, rupture or degradation of a portion of the wall ofthe pouch, or active deployment wherein, for example, a material in thepouch or reservoir swells upon wetting and forces expulsion of theactive ingredient, or a foam is generated to carry the active ingredientout of the pouch.

Nonwoven or film components such as a liquid-pervious cover layer orother component can also be combined with active ingredients in avariety of means. The active ingredient can be attached to the surfaceof the nonwoven or film, or may be incorporated into the solid matrix.For example, an active ingredient can be blended in one or more polymerphases prior to manufacture of the nonwoven or film, or can be addedinto the solid phase as a post treatment by a variety of means,including delivery in a supercritical fluid carrier. With polyolefinpolymers and other compounds, the presence of supercritical carbondioxide, for example, causes substantial swelling of the polymer,creating large pore spaces in the swollen state into which an activeingredient can diffuse. Removal of the supercritical carbon dioxide thencauses reversal of the swelling, resulting in trapping of the activeingredient within the solid matrix of the nonwoven or film, with thepossibility for gradual release of the active ingredient from the matrixwhen in contact with biological membranes or fluids, especially uponwetting.

Alternately, vehicles with various degrees of complexity can be usedranging from simple vehicles made of a singular substance to gels,liquids, emulsions, solids, powders or to even more complex vehiclessuch as those containing liposomes or particulate materials bearingspecific ligands with which to target the agent to particular locationswithin the vaginal environment. In other embodiments, the device couldinclude degradable hollow fibers or other structures wherein the cavityis filled with the agent. In this way the material would be releasedonly in response to specific events. In still other embodiments, theabsorption of the therapeutic agent can be augmented with penetrationenhancers.

Apertured webs can also be used to contain an active ingredient, eitheras a substrate or component in a laminated structure. The webs that canbe used include those of Tredegar Corp. and AET Specialty Nets &Nonwovens, including the latter's includes DELNET-brand geometricapertured fabrics, DELNET-EP-brand coextruded adhesive fabrics,PLASTINET-brand biplanar netting and sleeving, STRATEX-brand engineeredlaminated structures, and DELPORE-brand, DELGUARD-brand andDELSORB-brand meltblown nonwoven fabrics, any of which can be treatedwith or combined with active ingredients. Active ingredients can also beprovided as an internal component of a laminated structure, such as acentral layer in a laminate between two film layers.

Foam components can also be combined with active ingredients. Activeingredients can be directly mixed with the solid matter forming thematrix of the foam, or can be contained as a solid phase such asparticulates or as a viscous phase within the open or enclosed cells ofthe foam. Release of the active ingredient can occur upon wetting,wither by solvating the active ingredient from the solid matrix,dissolving the walls of an encapsulating medium, or permitting adiffusion pathway back to mucosal membranes. Foam matrices can includeregenerated cellulose; synthetic polymers such as polyurethane; gelatinor other protein-based compositions such as those derived from albumin;High-Internal-Phase-Ratio Emulsions (HIPE) technology such as thatdisclosed in U.S. Pat. No. 5,652,194, “Process for Making Thin-WetAbsorbent Foam Materials for Aqueous Body Fluids,” issued Jul. 29, 1997to Dyer et al.; and fiber-based foam compositions such as thosedisclosed in U.S. Pat. No. 6,261,679, “Fibrous Absorbent Material andMethods of Making the Same,” issued Jul. 17, 2001 to F-J. Chen et al.

Cellulose fibers can be combined with active ingredients in a variety ofways, including attachment by chemical or physiochemical means such asvan der Waals forces, covalent bonds or ionic bonds; physicalentanglement (being mechanically trapped by the porous structure); orlumen loading, wherein the active ingredient is chemically ormechanically deposited into the hollow lumen or core of a naturalcellulose fiber or a synthetic fiber, as disclosed in U.S. Pat. No.4,510,020, issued to H. V. Green et al., Apr. 9, 1985; or U.S. Pat. No.5,096,539, issued to G. G. Allan, Mar. 17, 1992. The same can be donefor hollow non-cellulose fibers. Cellulose webs can also be impregnatedor coated with active ingredients, either alone or in combination withhydrophobic matter, hydrogels, or other carriers, as disclosed, forexample, in U.S. Pat. 5,990,377, “Dual-zoned Absorbent Webs,” issuedNov. 23, 1999 to F-J. Chen et al.

Active ingredients can also be combined with an active deployment meansthat physically moves the active ingredient after being triggered bywetting or an increase in temperature. For example, the activedeployment means can comprise generation of foam or bubbles in aneffervescent effect that can move the active ingredient from within theabsorbent article toward the body of the user, triggered by contact withan aqueous fluid, for example. A swellable material placed with theactive ingredient in a pouch with a liquid-pervious inelastic wall canswell upon wetting and force expulsion of the active ingredient from thepouch.

In an alternate embodiment, a reservoir is provided in or on the tampon(not shown) in which to locate the therapeutic agent. The agent may bestored within the reservoir in various forms and in varying dosages. Forexample, the agent may be placed in the reservoir in liquid form, insolid form, or in an encapsulated form. The agent may be formulated toact immediately upon insertion of the tampon 22, or in a time-releasemanner. The agent may be activated by pressure form the insertion, orfrom pressure, heat, or humidity in the vaginal environment. The agentmay be placed by the manufacturer of the tampon or the tampon user asneeded.

For example, the agent may be encapsulated and located within thereservoir. Insertion pressure on the tampon body 50 from the secondmember 18 ruptures the capsule, releasing the agent into the surroundingtampon material and thus to the vaginal epithelium.

The therapeutic agent may be combined into a formulation that maycontain other additives or carrier components as appropriate for thedesired result so long as the additives or carrier components do nothave a major detrimental effect on the activity of the therapeuticagent. Examples of such additives include additional conventionalsurfactants, such as esters like myreth-3-myristate, ethoxylatedhydrocarbons, or ionic surfactants, or co-wetting aids such as lowmolecular weight alcohols. The formulation is desirably applied fromhigh solids, advantageously 80% or less solvent or water, so as tominimize drying and its attendant costs and deleterious effects. Thetreating formulation may be applied in varying amounts depending on thedesired results and application. Those skilled in the art can readilyselect the actual amount based on the teaching of this application. Forexample, a catamenial tampon 22 designed to be inserted into a bodycavity and subsequently in intimate contact with the vaginal epitheliummay require substantially less therapeutic agent than an absorbentarticle worn exterior to the body due to the absence of first pass livermetabolism as previously discussed.

It will be recognized by those skilled in this art that a therapeuticagent may be used as an internal additive, that is, added to the polymermelt directly or in a concentrate form. After fiber formation, suchadditives can migrate to the fiber surface and impart the desiredeffect. For further discussion of internal addition of additives, seefor example, U.S. Pat. No. 5,540,979, the contents of which areincorporated herein by reference. The substrate basis weight is notcritical and may vary widely depending on the application. The thermaland oxidation stability of the therapeutic agent must be compatible withthe temperature and rheology required for melt processing.

The formulation including a therapeutic agent of the present inventioncan be prepared and applied in other suitable forms, including withoutlimitation, aqueous solutions, emulsions, lotions, balms, gels, salves,powders, ointments, muco-adhesives, boluses, suppositories, and thelike. The formulations of this invention may also contain preservatives.Compounds that can impart greater viscosity, such as polyethylene glycoland the like, may also be added to the formulations of this invention.Generally, higher viscosity formulations are preferred to createformulations that will tend to remain in the vagina for a relativelylong time period after administration.

A formulation including a therapeutic agent may additionally employ oneor more conventional pharmaceutically-acceptable and compatible carriermaterials useful for the desired application. The carrier can be capableof co-dissolving or suspending the materials used in the formulationincluding a therapeutic agent. Carrier materials suitable for use in theinstant formulation including a therapeutic agent, therefore, includethose well-known for use in the pharmaceutical, cosmetic, and medicalarts as a basis for ointments, lotions, creams, salves, aerosols,suppositories, gels and the like.

In use, and referring to FIG. 2, the applicator 10 functions because thesecond member 18 is telescopically movable relative to the first member14. As the second member 18 is pushed into the first member 14, thetampon 22 is forced forward against the pleats or petals 36. The contactby the tampon 22 causes the pleats 36 to radially open to a diameterthat is sufficient to allow the tampon 22 to be expelled from the firstmember 14. With the tampon 22 properly positioned in the woman's vaginalcavity, the tampon applicator 10 is withdrawn and properly discarded.

Once the tampon 22 is properly positioned in the woman's vaginal cavity,the tampon body 50 may absorb menses and other bodily fluids, and thetampon body 50 may also deliver the therapeutic agent to the vaginalepithelium. From there, the therapeutic agent is transferred to theuterus by normal bodily functions to relieve the condition to betreated.

The invention has been described with reference to various specific andillustrative embodiments and techniques. However, it should beunderstood that many variations and modifications may be made whileremaining within the spirit and scope of the invention.

Accordingly, this invention is intended to embrace all suchalternatives, modifications and variations that fall within the spiritand scope of the appended claims.

1. A tampon adapted to deliver a therapeutic agent, the tamponcomprising absorbent material and a formulation including a therapeuticagent, wherein the therapeutic agent is a botanical, wherein the tamponhas an outer layer, and wherein the outer layer includes atherapeutically sufficient amount of the botanical.
 2. The tampon ofclaim 1, wherein the therapeutic agent is a salve.
 3. The tampon ofclaim 1, wherein the outer layer is a cover.
 4. The tampon of claim 3,wherein the cover is liquid-permeable.
 5. The tampon of claim 4, whereinthe liquid-permeable cover is a porous nonwoven sheet.
 6. The tampon ofclaim 5, wherein the porous nonwoven sheet is a spunbond web formed frompolypropylene or polyethylene fibers or a mixture thereof.
 7. The tamponof claim 6, wherein the botanical is coated on the fibers.
 8. The tamponof claim 5, wherein the porous nonwoven sheet is formed from fibers ofhydrophobic polymer.
 9. The tampon of claim 8, wherein the botanical iscoated on the fibers.
 10. The tampon of claim 1, wherein the therapeuticagent is an ointment.
 11. The tampon of claim 1, wherein the botanicalis distributed throughout the absorbent material.
 12. The tampon ofclaim 1, wherein the botanical is selected from the group consisting ofAgnus castus, aloe vera, comfrey, calendula, dong quai, black cohosh,chamomile, evening primrose, Hypericum perforatum, black currant seedoil, St. John's wort, tea extracts, lemon balm, capsicum, rosemary,Areca catechu, mung bean, borage seed oil, witch hazel, fenugreek,lavender, and soy.
 13. The tampon of claim 1, wherein the botanical is aVaccinium extract derived from a plant selected from the groupconsisting of: heath, cranberries, blueberries, azaleas, red onion skin,short red bell peppers, long red bell peppers, beet root extract, andcapsanthin.
 14. The tampon of claim 1, wherein the botanical is selectedfrom the group consisting of: whortleberry, lingenberry, chokeberry,sweet rowan, rowanberry, seabuckhrouberry, crowberry, strawberries, andgooseberries.
 15. The tampon of claim 1, wherein the therapeutic agentis a combination of a botanical and a beneficial agent selected from thegroup consisting of: vitamins, calcium, magnesium, hormones, analgesics,prostaglandin inhibitors, prostaglandin synthetase inhibitors,leukotriene receptor antagonists, essential fatty acids, sterols,anti-inflammatory agents, vasodilators, chemotherapeutic agents, andagents to treat infertility.
 16. The tampon of claim 1, furthercomprising non-absorbent material.
 17. The tampon of claim 1, furthercomprising a reservoir, wherein the therapeutic agent is locatedsubstantially within the reservoir.
 18. The tampon of claim 17, whereinthe tampon has a surface, and wherein the reservoir is in communicationwith the surface.
 19. The tampon of claim 17, wherein the tampon has asurface, and wherein the reservoir is located under the surface.
 20. Thetampon of claim 1, wherein the therapeutic agent is substantially aliquid.
 21. The tampon of claim 1, wherein the therapeutic agent is anemulsion.
 22. The tampon of claim 1, wherein the therapeutic agent is apowder.
 23. The tampon of claim 1, wherein the therapeutic agent is agel.
 24. The tampon of claim 1, wherein the tampon includes an aperturedweb, and wherein the formulation including a therapeutic agent iscontained in the apertured web.
 25. The tampon of claim 1, wherein theabsorbent material has an interstitial space, and wherein theformulation including a therapeutic agent is interspersed within theinterstitial space.
 26. The tampon of claim 1, wherein the therapeuticagent is substantially a solid.
 27. The tampon of claim 1, wherein thetherapeutic agent is substantially a semi-solid.
 28. The tampon of claim1, wherein the therapeutic agent is encapsulated.
 29. The tampon ofclaim 1, further comprising an applicator, wherein pressure applied bythe applicator to the tampon releases the formulation including thetherapeutic agent.
 30. The tampon of claim 1, wherein the formulationincludes a ligand adapted to target the therapeutic agent.
 31. Thetampon of claim 1, further comprising a pledget, wherein the formulationincluding a therapeutic agent is applied to the pledget.
 32. The tamponof claim 1, wherein the tampon includes a surface, and wherein theformulation including a therapeutic agent is applied to the surface. 33.The tampon of claim 1, wherein the tampon includes a compressed body,and wherein the formulation including a therapeutic agent is applied tothe body after the body is compressed.
 34. The tampon of claim 1,wherein the tampon includes a body constructed from a material, andwherein the formulation including a therapeutic agent is applied to thematerial before the body is constructed.
 35. The tampon of claim 1,wherein the formulation including a therapeutic agent is applied todegradable fibers.
 36. The tampon of claim 1, wherein the formulationincluding a therapeutic agent includes a polymeric material.
 37. Thetampon of claim 1, wherein the formulation including a therapeutic agentincludes a foam component.
 38. The tampon of claim 1, wherein theformulation including a therapeutic agent includes a hydrogel material.39. A tampon adapted to deliver a therapeutic agent, the tamponcomprising a body and a formulation including a therapeutic agent,wherein the therapeutic agent is a botanical wherein the tampon has anouter layer, and wherein the outer layer includes a therapeuticallysufficient amount of the botanical.
 40. The method of claim 39, whereinthe manufacturing act includes compressing the body, and wherein thelocating act includes applying the formulation including a therapeuticagent to the body after the body is compressed.
 41. The method of claim39, wherein the manufacturing act includes manufacturing the body toinclude an apertured web, and wherein the locating act includescontaining the formulation including a therapeutic agent in theapertured web.
 42. A device for delivering a therapeutic agent, thedevice comprising: a tampon body including absorbent material, whereinthe tampon body has a surface; and means for carrying a formulationincluding a therapeutic agent within the body, wherein the therapeuticagent is a botanical, and wherein the carrying means is substantiallypositioned adjacent the surface.
 43. The device of claim 42, wherein thebody has a reservoir, and wherein the carrying means is substantiallypositioned within the reservoir.
 44. A method of producing a tamponadapted to deliver a therapeutic agent, the method comprising: treatinga porous nonwoven sheet formed from hydrophobic polymer with aformulation including a therapeutic agent, wherein the therapeutic agentis a botanical; and forming the tampon so as to include absorbentmaterial, such that the sheet at least partially covers the tampon. 45.A method of treating a woman via the vaginal epithelium, the methodcomprising: exposing the epithelium to a formulation including atherapeutic agent residing on a tampon, the therapeutic agent includinga botanical, wherein the tampon has an outer layer, wherein the outerlayer includes a therapeutically sufficient amount of the botanical, andwherein the botanical is selected from the group consisting of Agnuscastus, aloe vera, comfrey, calendula, black cohosh, chamomile, eveningprimrose, Hypericum perforatum, black currant seed oil, St. John's wart,tea extracts, lemon balm, capsicum, rosemary, Areas catechu, mung bean,borage seed oil, witch hazel, fenugreek, lavender, soy, heath,cranberries, blueberries, azaleas, red onion skin, short red bellpeppers, long red bell peppers, beet root extract, capsanthin,whortleberry, lingenberry, chokeberry, sweet rowan, rowanberry,seabuckhrouberry, crowberry, strawberries, and gooseberries.
 46. Themethod of claim 45, wherein the exposing act includes a therapeuticagent that is a combination of a botanical and a beneficial agentselected from the group consisting of: vitamins, calcium, magnesium,hormones, analgesics, prostaglandin inhibitors, prostaglandin synthetaseinhibitors, leukotriene receptor antagonists, essential fatty acids,sterols, anti-inflammatory agents, vasodilators, chemotherapeuticagents, and agents to treat infertility.
 47. A tampon adapted to delivera therapeutic agent, the tampon comprising absorbent material and aformulation including a therapeutic agent, wherein the therapeutic agentis a botanical, wherein the tampon has an outer layer, and wherein thetherapeutic agent is positioned essentially within the outer layer.